Update from the AHA 2010

Jonathan SilberbergFebruary 2011

Part 1. Trials• Rocket-AF• Closure I• Emphasis-HF• SMART• Fish oil and AF• Symplicity-HTN 2

Rocket-AF

• Trial of rivaroxiban in AF• oral Factor Xa inhibitor• Half life 5-12 hours, given once

daily• Dose reduction in renal failure

Rocket-AF

• High CHAD-2 score ~3.5 ave• 90% >3, cf. previous trials ~2.0• 55% prior stroke• 63% heart failure, 40% diabetes• N=14,171

Rocket-AF

• warfarin-treated target INR 2-3• Median time in range 58%• Over range12%• Under range 20%• Up to 40 months followup

Rocket-AFRivaroxaban Warfarin

N 7081 7090

Intracranial/cerebral bleed 84 55

Stroke or embolism 269 306

‘Primary endpoint’ 2.12% 2.42%

‘noninferiority’ 1.71% 2.16%

Patients were already stable on warfarin before randomisation

conclusions• Warfarin monitoring is suboptimal even

in well-funded trials• Under-anticoagulation protects against

bleeding; more consistent treatment brings higher bleeding rates

• Absolute stroke rates may be overestimated

• Benefits of treatment are small

StarFlex Closure I

• N=909• Age 18 to 60• Cryptogenic stroke and PFO• Open label • ASA or WarfarinvsStarFlex with

ASA/clopidogrel

StarFlex Closure IDevice Medical

stroke/TIA/ neuro deathWithin 2 years

5.5% 7.7%

Stroke in 2 years 3.1% 3.4%

Recurrent stroke 23 29

Alternative cause 20 22

PFO is usually incidental to stroke

Emphasis-1

• Eplerenone in mild heart failure• N=2737, average 5 years CHF• EF <35%; NYHA class II• 65% coronary disease• median 21 mo followup

Emphasis-1eplerenone placebo

CV death 10.8% 13.5%

hospitalisation 12.0% 18.4%

Death or hospital 18.3% 25.9%

Absolute 15.5% vs 12.5%NNT 33 for 3 years

EMPHASIS-1

SMART

• A-V delay in CRT (biventricular pacing)

• N=980, CHF with mean EF 24%• Empirical 120 msecvs• H’dynamic max dP/dtvs• Supine echo algorithm

Fish oil and AF

• N=542 paroxysmal AF• N=121 persistent AF• 4g omega-3 vs placebo• 24 weeks

Fish oil and AF

Participants were at least 18 years old and had a confirmed diagnosis of either symptomatic paroxysmal AF that had never been treated by long-term pharmacological or electrical therapy to terminate an AF episode

or had a diagnosis of symptomatic persistent AF, defined as AF that had been previously successfully treated with pharmacological or electrical cardioversion at least 1 time and were currently in normal sinus rhythm.

Fish oil and AF

Inclusion required at least 1 suspected ordocumented episode of symptomaticAF within 3 months of screening andat least 1 electrocardiographicallydocumented episode of symptomaticAF within 12 months of screening.

Symplicity-HTN 2

• Ardian device renal denervation• SBP >160 despite 3 drugs• Omron automatic oscillometry• home and office BP• 84/190 fell <160 during run-in

Next week...part 2

• Cardiac hypertrophy• Decompensated heart failure• Brown & Goldstein• PHT in heart failure• LDL cholesterol• Thoracic aorta